Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021575
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FOSAMAX | ALENDRONATE SODIUM | EQ 70MG BASE/75ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/17/2003 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21575_fosomax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21575ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-575_Fosamax.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/30/2015 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s069,021575Orig1s025ltr.pdf | |
| 04/08/2015 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020560Orig1s068,021575Orig1s024ltr.pdf | |
| 12/23/2013 | SUPPL-23 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s066;021575Orig1s023ltr.pdf | |
| 04/19/2013 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020560Orig1s065,021575Orig1s022ltr.pdf | |
| 07/01/2011 | SUPPL-21 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s061,021575s021ltr.pdf |
| 01/25/2011 | SUPPL-20 | REMS |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020560s060,021575s020ltr.pdf | |
| 03/01/2010 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf | |
| 02/06/2012 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021575s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf | |
| 03/01/2010 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf | |
| 10/08/2008 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf | |
| 03/01/2010 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf | |
| 12/28/2006 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf | |
| 12/28/2006 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf | |
| 11/02/2005 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf | |
| 12/21/2005 | SUPPL-7 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s038,021575s007.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020560s038_021575s007lbl.pdf |
| 12/01/2004 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf | |
| 12/01/2004 | SUPPL-5 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560s043,044,21575s005,006ltr.pdf | |
| 04/16/2004 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560se8-041,21575slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021575_s004_FOSAMAX TABS.pdf | |
| 02/20/2004 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr042,21517slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020560_S042 & 021575_S003_FOSAMAX_TABS_ORAL_SOLUTION_AP.pdf | |
| 04/27/2004 | SUPPL-2 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20560slr030,21575slr002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/30/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s069,021575s025lbl.pdf | |
| 04/08/2015 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020560s068,021575s024lbl.pdf | |
| 12/23/2013 | SUPPL-23 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s066,021575s023lbl.pdf | |
| 04/19/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020560s065,021575s022lbl.pdf | |
| 02/06/2012 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021575s017lbl.pdf | |
| 01/25/2011 | SUPPL-20 | REMS | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020lbl.pdf | |
| 03/01/2010 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf | |
| 03/01/2010 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf | |
| 03/01/2010 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020560s051s055s057,021575s012s016s018lbl.pdf | |
| 10/08/2008 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020560s052,021575s013,021762s006lbl.pdf | |
| 12/28/2006 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf | |
| 12/28/2006 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020560s47s48,021575s10s11,021762s2s3lbl.pdf | |
| 11/02/2005 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021575s009,020560s046lbl.pdf | |
| 12/01/2004 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf | |
| 12/01/2004 | SUPPL-5 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560s043,044,21575s005,006lbl.pdf | |
| 04/16/2004 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560se8-041,21575slr004_fosamax_lbl.pdf | |
| 02/20/2004 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr042,21517slr003_fosamax_lbl.pdf | |
| 09/17/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21575_fosomax_lbl.pdf |